Oral Poliomyelitis Vaccines (Oral Drops)
Poliomyelitis vaccines (trivalent live, oral, innactivated, type 1,2, 3)
Product Details
WHO Product ID
FVP-P-400
Status
Prequalified
Date of prequalification
Vaccine type
Poliomyelitis vaccines (trivalent live, oral, innactivated, type 1,2, 3)
Abbreviated Name
tOPV
Commercial Name
Oral Poliomyelitis Vaccines (Oral Drops)
PQ Holder
PT Bio Farma (Persero)
Jl. Pasteur 28
Bandung,
40161
Indonesia
Responsible NRA
National Agency of Drug and Food Control Indonesia (NADFCI)
Product description
Pharmaceutical Form
Liquid: Ready to use
Presentation
Vial
Number of doses
20
Route of administration
Oral
Vaccine Vial Monitor
None
Multidose Vial Policy
WHO recommends that opened vials of this vaccine should be discarded 6 hours after opening or at the end of the immunization session, whichever comes first.
Shelf life (months)
24 months
Storage temperature
-20°C
Diluent
N/A
Preservative
None
Remarks
No Vaccine Vial Monitor (VVM) is currently suitable for the vaccine based on accelerated and stress stability studies results. PT Bio Farma (Persero) has initiated discussions to develop a suitable VVM category.
Product Packaging
Secondary Container
Shipping Container
Component Packed
Active (Vaccine)
Total doses
10
Description
Carton of 10 vials (200 doses)[Dimensions: 8.5 x 4.2 x 3.8 cm]
Dimensions
8.5 x 4.2 x 3.8 cm
Cold Chain Volume (cm³/dose)
0.68
Component Packed
Active (Vaccine)
Total doses
10
Description
Carton of 50 vials (1000 doses) [Dimensions: 17 x 3.8 x 8.5 cm].
Dimensions
17.0 x 3.8 x 8.5 cm
Cold Chain Volume (cm³/dose)
0.55
